More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL) (MaximALL)
"MaximALL" More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
Studieoversikt
Status
Status
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Studietype
Registrering (Antatt)
Registrering
Fase
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
Studiekontakt
- Navn: Axel Karow, PD. Dr. med.
- Telefonnummer: 09131 8533118
- E-post: axel.karow@uk-erlangen.de
Studer Kontakt Backup
- Navn: Ferdinand Knieling, Prof. Dr. med.
- Telefonnummer: 09131 8533118
- E-post: ferdinand.knieling@uk-erlangen.de
Studiesteder
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-
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Erlangen, Tyskland, 91054
- Rekruttering
- Department of Pediatrics and Adolescent Medicine
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Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Control Group:
Inclusion Criteria:
- no cancer diagnosis
- no lung diseases
- no vascular diseases
- No subjective reduction in physical performance
- age >/= 18 years
Exclusion Criteria:
- Pregnancy, Lactation
- Known pleural or pericardial effusion
- Critical condition (requiring respiratory support, ventilation, oxygen, shock, symptomatic heart failure)
- Marked thoracic deformities/malformations
- Previous lung surgery
- Injuries that do not allow physical stress diagnostics
- Rejection of MRI imaging
- General contraindications for MRI examinations (e.g. electrical implants such as cardiac pacemakers or perfusion pumps, copper IUD etc.)
Survivors of ALL:
Inclusion Criteria:
- Completed therapy for ALL
- age >/= 3 years
Exclusion Criteria:
- Pregnancy, Lactation
- Known pleural or pericardial effusion
- Critical condition (requiring respiratory support, ventilation, oxygen, shock, symptomatic heart failure)
- Marked thoracic deformities/malformations
- Previous lung surgery
- Injuries that do not allow physical stress diagnostics
- Rejection of MRI imaging
- General contraindications for MRI examinations (e.g. electrical implants such as cardiac pacemakers or perfusion pumps, copper IUD etc.)
Survivors of Lymphoma:
Inclusion Criteria:
- Completed therapy for lymphoma
- age >/= 3 years
Exclusion Criteria:
- Pregnancy, Lactation
- Known pleural or pericardial effusion
- Critical condition (requiring respiratory support, ventilation, oxygen, shock, symptomatic heart failure)
- Marked thoracic deformities/malformations
- Previous lung surgery
- Injuries that do not allow physical stress diagnostics
- Rejection of MRI imaging
- General contraindications for MRI examinations (e.g. electrical implants such as cardiac pacemakers or perfusion pumps, copper IUD etc.)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Antall våpen
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
|---|---|
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Annen: Control Group
Healthy individuals with no previous cancer diagnosis.
Volunteers will receive physical examination, standardized pulmonary function testing including spirometry and assessment of the diffusing capacity of the lung for carbon monoxide (DLCO) using a single-breath technique and MRI on a low field system (Lung and heart).
Furthermore, cardiopulmonary testing (spiroergometry and echocardiography) is performed.
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During this non-invasive test, the subject must breathe against resistance through a mouthpiece.
DLCO measurement is a non-invasive pulmonary function test for Pulmonary Diffusion Capacity.
Echocardiography with strain-rate imaging.
LF-MRI for detection of morphological and functional changes in the lung and heart.
Recording patient information (Age, Gender, Weight and height, Ethnicity, current medication, measurement of blood pressure and blood oxygen saturation.
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Annen: Survivors of leukemia
Survivors of treatment for acute lymphatic leukemia in childhood or adolescence.
Participants will receive physical examination, standardized pulmonary function testing including spirometry and assessment of the diffusing capacity of the lung for carbon monoxide (DLCO) using a single-breath technique and MRI on a low field system (Lung and heart).
Furthermore, cardiopulmonary testing (spiroergometry and echocardiography) and multispectral optoacoustic tomography (MSOT) for Peripheral artery disease (PAD) are performed.
compliant data storage).
In addition, venous blood samples will be taken for the analysis of molecular biomarkers.
|
During this non-invasive test, the subject must breathe against resistance through a mouthpiece.
DLCO measurement is a non-invasive pulmonary function test for Pulmonary Diffusion Capacity.
Echocardiography with strain-rate imaging.
LF-MRI for detection of morphological and functional changes in the lung and heart.
Recording patient information (Age, Gender, Weight and height, Ethnicity, current medication, measurement of blood pressure and blood oxygen saturation.
QoL assessment by EORTC SURV100, PPR
Blood samples for further molecular testing regarding epigenetic aging markers and telomere biology parameters.
multispectral optoacoustic tomography of musculus gastrocnemius bilaterally for screening of PAD
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Annen: Survivors of lymphoma
Survivors of treatment for lymphoma in childhood or adolescence.
Participants will receive physical examination, standardized pulmonary function testing including spirometry and assessment of the diffusing capacity of the lung for carbon monoxide (DLCO) using a single-breath technique and MRI on a low field system (Lung and heart).
Furthermore, cardiopulmonary testing (spiroergometry and echocardiography) and multispectral optoacoustic tomography (MSOT) for Peripheral artery disease (PAD) are performed.
compliant data storage).
In addition, venous blood samples will be taken for the analysis of molecular biomarkers.
|
During this non-invasive test, the subject must breathe against resistance through a mouthpiece.
DLCO measurement is a non-invasive pulmonary function test for Pulmonary Diffusion Capacity.
Echocardiography with strain-rate imaging.
LF-MRI for detection of morphological and functional changes in the lung and heart.
Recording patient information (Age, Gender, Weight and height, Ethnicity, current medication, measurement of blood pressure and blood oxygen saturation.
QoL assessment by EORTC SURV100, PPR
Blood samples for further molecular testing regarding epigenetic aging markers and telomere biology parameters.
multispectral optoacoustic tomography of musculus gastrocnemius bilaterally for screening of PAD
|
Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Morphological lung changes (MRI)
Tidsramme: Single time point
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Morphological lung changes
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Single time point
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Functional lung parameters (MRI)
Tidsramme: Single time point
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Ventilation match/mismatch, Perfusion match/mismatch, combined defects
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Single time point
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Quantitative and functional cardiovascular changes (MRI)
Tidsramme: Single time point
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Quantitative and functional cardiovascular changes of the heart
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Single time point
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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DLCO
Tidsramme: Single time point
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diffusing capacity of the lungs for carbon monoxide (absolute value and % of predicted value)
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Single time point
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VA
Tidsramme: Single time point
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Alveolar Volume
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Single time point
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KCO
Tidsramme: Single time point
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DLCO/VA (absolute and % of predicted value)
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Single time point
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VC
Tidsramme: single time point
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VC (vital capacity) in %
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single time point
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FEV1
Tidsramme: Single time point
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FEV1 (Forced Expiratory Volume in 1 Second) in %
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Single time point
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VO2
Tidsramme: Single time point
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Oxygen uptake (VO2)
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Single time point
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VO2max
Tidsramme: Single time point
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peak oxygen uptake (VO2max)
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Single time point
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RER
Tidsramme: Single time point
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Respiratory exchange ratio (RER)
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Single time point
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VT2
Tidsramme: Single time point
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Ventilatory anaerobic threshold (VT2)
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Single time point
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VCO2
Tidsramme: Single time point
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Carbon dioxide output (VCO2)
|
Single time point
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HR
Tidsramme: Single time point
|
Heart rate (HR)
|
Single time point
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HRR
Tidsramme: Single time point
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Heart Rate Reserve (HRR)
|
Single time point
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Breath rate at VAT
Tidsramme: Single time point
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Breath rate at VAT
|
Single time point
|
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BRR
Tidsramme: Single time point
|
Breath rate reserve (BRR)
|
Single time point
|
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VE
Tidsramme: Single time point
|
minute ventilation (VE)
|
Single time point
|
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O2 Pulse
Tidsramme: Single time point
|
O2 Pulse
|
Single time point
|
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HRV
Tidsramme: Single time point
|
Heart rate variability (HRV)
|
Single time point
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Borg Scale
Tidsramme: Single time point
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Exercise capacity (Borg Scale)
|
Single time point
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Echocardiography
Tidsramme: Single time point
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Myocardial function by echocardiographic strain and strain-rate imaging
|
Single time point
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Clinical parameters 1
Tidsramme: Single time point
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Age in years
|
Single time point
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Clinical parameters 2
Tidsramme: Single time point
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Gender
|
Single time point
|
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Clinical parameters 3
Tidsramme: Single time point
|
Weight
|
Single time point
|
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Clinical parameters 4
Tidsramme: Single time point
|
Ethnicity
|
Single time point
|
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Clinical parameters 5
Tidsramme: Single time point
|
Time from therapy initiation/Interval until study day
|
Single time point
|
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Clinical parameters 6
Tidsramme: Single time point
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Current medication*
|
Single time point
|
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Clinical parameters 7
Tidsramme: Single time point
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Secondary diagnoses
|
Single time point
|
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Blood pressure
Tidsramme: Single time point
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Blood pressure measurement
|
Single time point
|
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Clinical examination
Tidsramme: Single time point
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Standard clinical examination
|
Single time point
|
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Questionnaire regarding psychosocial aspects
Tidsramme: Single time point
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EORTC-SURV100 PPR (Posttraumatische Persönliche Reifung) Adapted Decision Regret questionnaire for childhood cancer survivors
|
Single time point
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Blood samples 1
Tidsramme: Single time point
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Presence of clonal hematopoiesis (CH)
|
Single time point
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Blood samples 2
Tidsramme: Single time point
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Type of CH-associated gene mutations (e.g.
DNMT3A, TET2, DDR genes)
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Single time point
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Blood samples 3
Tidsramme: Single time point
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Clone size / variant allele frequency (VAF)
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Single time point
|
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Blood samples 4
Tidsramme: Single time point
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Epigenetic aging markers (e.g.
epigenetic age acceleration measures)
|
Single time point
|
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Blood samples 5
Tidsramme: Single time point
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Telomere biology parameters (e.g.
telomere length-related measures)
|
Single time point
|
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Blood samples 6
Tidsramme: Single time point
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biomarkers for long-term pulmonary dysfunction (WFDC2, TNFR1, MMP2, SPD18)
|
Single time point
|
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MSOT 1
Tidsramme: Single time point
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Oxygenated haemoglobin (HbO₂)
|
Single time point
|
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MSOT 2
Tidsramme: Single time point
|
Deoxygenated haemoglobin (HHb)
|
Single time point
|
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MSOT 3
Tidsramme: Single time point
|
Total haemoglobin (tHb)
|
Single time point
|
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MSOT 4
Tidsramme: Single time point
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Tissue oxygen saturation (sO₂)
|
Single time point
|
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MSOT 5
Tidsramme: Single time point
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MSOT signal intensity per region of interest
|
Single time point
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MSOT 6
Tidsramme: Single time point
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MSOT topogram of perfusion of the m.
gastrocnemius
|
Single time point
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Samarbeidspartnere og etterforskere
Sponsor
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Studiestart
Primær fullføring (Antatt)
Primær fullføring
Studiet fullført (Antatt)
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Først lagt ut
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Sist oppdatering lagt ut
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Neoplasmer
- Sykdommer i immunsystemet
- Neoplasmer etter histologisk type
- Hematologiske sykdommer
- Lymfesykdommer
- Lymfoproliferative lidelser
- Immunproliferative lidelser
- Leukemi, lymfoid
- Leukemi
- Hemic og lymfatiske sykdommer
- Lymfom
- Forløpercelle lymfoblastisk leukemi-lymfom
- Undersøkelsesteknikker
- Prøvehåndtering
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og prosedyrer
- Diagnose
- Punkteringer
- Kirurgiske prosedyrer, operativ
- Diagnostiske teknikker, luftveissystem
- Åndedrettsfunksjonstester
- Blodprøveinnsamling
- Spirometri
Andre studie-ID-numre
Andre studie-ID-numre
- MaximALL
- DKS 2025.17 (Annet stipend/finansieringsnummer: Deutsche Kinderkrebsstiftung)
- 2026-03 (Annet stipend/finansieringsnummer: Verein zur Förderung des Tumorzentrums und des CCC Erlangen-EMN der Universität Erlangen-Nürnberg e.V.)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request as follows:
Individual participant data will not be available Study Protocol and Statistical Analysis Plan will be available The data will be available beginning 9 months and ending 36 months following article publication.
The data will be available to researchers who provide a methodologically sound proposal.
The data will be available for individual participant data meta-analysis, only. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at https://www.uk-erlangen.de.
Restrictions may apply due to patient privacy and the General Data Protection Regulation.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
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